Clinical trials found treatment could shrink tumors

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WASHINGTON — The Food and Drug Administration on Thursday approved a cancer drug made by pharmaceutical giant Eli Lilly and Co. to treat advanced non-small cell lung cancer in patients who have undergone chemotherapy.

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

According to the American Cancer Society, non-small cell lung cancer is the leading cause of cancer-related deaths in the nation. Eighty percent of 174,000 new lung cancer cases diagnosed each year are non-small cell lung cancer. By the time most patients arrive for treatment, the cancer is widespread.

The drug, Alimta, in clinical trials was found to shrink tumors as effectively as another cancer-fighting drug, Taxotere. But Alimta did so with fewer troubling side effects, which include hair loss, tingling fingers and toes, depressed blood count, and hospitalizations for subsequent infection.

"Lung cancer is a very devastating disease and the therapies can be hard on patients," said Roy Herbst, chief of thoracic oncology at MD Anderson Cancer Center. The Houston, Texas, facility sees nearly 1,500 new lung cancer patients per year and treated at least 20 in the Alimta vs. Taxotere study.

One in 50 patients taking Alimta had side effects. That benefit came without any lessening of the drug's effectiveness. That's significant as cancer care moves toward more combination drug or sequential therapies, Herbst said.

"We can only do that if the drugs we give (patients) leave them in a state ... where they're still strong. You can kill the cancer, but leave the patient feeling well," he said.

The Alimta treatment, 500 mg every 21 days, costs patients $3,900 per month, according to the company. The anti-cancer drug works by interfering with three enzymes on which tumors depend.

"There's no question, the survival was comparable to the survival with the best drugs we have," said Dr. Paul Bunn, director of the University of Colorado Cancer Center and principal investigator for the clinical trial. "This drug is as good as anything else we have. It does benefit patients."

Dr. Richard Gralla, president of the New York Lung Cancer Alliance, estimated tens of thousands of lung-cancer patients per year would be eligible to take Alimta.

The trial tested a simple way to reduce side effects: Taking Alimta in concert with folate pills and B-12 injections.

"When you take those special B vitamins, it further reduces the side effects of the chemotherapy," Gralla said.